Label: ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200 MG- aspirin and extended - release dipyridamole capsul...view full title
- NDC Code(s): 0904-7056-99
- Packager: Major Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 49884-007
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 14, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES safely and effectively. See full prescribing information for ASPIRIN AND ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEAspirin and Extended-Release Dipyridamole Capsule is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to ...
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2 DOSAGE AND ADMINISTRATIONAspirin and Extended-Release Dipyridamole Capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets. The recommended dose of Aspirin and ...
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3 DOSAGE FORMS AND STRENGTHS25 mg/200 mg capsules are imprinted in black with ‘PAR’ on the cap and ‘730’ on the body, containing yellow colored extended-release pellets incorporating dipyridamole and a white to off white ...
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4 CONTRAINDICATIONS4.1 Hypersensitivity - Aspirin and extended-release dipyridamole is contraindicated in patients with known hypersensitivity to any of the product components. 4.2 Allergy - Aspirin is ...
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5 WARNINGS AND PRECAUTIONS5.1 Risk of Bleeding - Aspirin and extended-release dipyridamole increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g. ...
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6 ADVERSE REACTIONSThe following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [see Contraindications (4.1)] • Allergy [see Contraindications (4.2)] • Risk of Bleeding ...
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7 DRUG INTERACTIONS7.1 Drug Interaction Study Information Obtained From Literature - Adenosinergic agents (e.g., adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole use during pregnancy have not identified a clear ...
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10 OVERDOSAGEBecause of the dose ratio of dipyridamole to aspirin, overdosage of aspirin and extended-release dipyridamole is likely to be dominated by signs and symptoms of dipyridamole overdose. In case of ...
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11 DESCRIPTIONAspirin and Extended-Release Dipyridamole Capsules are a combination of aspirin and dipyridamole, antiplatelet agents, intended for oral administration. Each hard gelatin capsule contains 200 mg ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - The antithrombotic action of aspirin and extended-release dipyridamole is the result of the additive antiplatelet effects of dipyridamole and ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks ...
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14 CLINICAL STUDIESESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGAspirin and Extended-Release Dipyridamole Capsules are available as a hard gelatin capsule, with a red colored cap and an ivory-colored body, containing yellow colored extended-release pellets ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information). • Risk of Bleeding - Inform patients that as with other antiplatelet agents, there is a general risk of ...
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Patient InformationAspirin and extended-release dipyridamole capsules - (as-per-in / ik-sten-did – ree-lees - dahy-pir-i-duh-mohl) Read this Patient Information before you start taking aspirin and extended-release ...
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Package/Label Display Panel MAJOR® NDC 0904-7056-99 - Unit Dose - Aspirin and - Extended-Release - Dipyridamole - Capsules - 25 mg/200 mg - 20 CAPSULES (5 x 4) Rx only
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INGREDIENTS AND APPEARANCEProduct Information